Telaprevir : An Easy To Understand Review

[Guest guest]

Telaprevir : An Easy To Understand Review

Reviewing Telaprevir

..

Here we go, I can only relate to you what I read online, I'm just a very charming woman who has no relationship with any CEO of Vertex. Wish I did, that sure would be exciting for this blog and me!

Call or send me an email Mr. Vertex.

..

Anyhoo, whats going on in the world of new HCV drugs ?

,

Great news on Telaprevir and the Advance Trial = Cure Rates @ 75 Percent , more on this later.

...

Not much else at the moment everyone is waiting for the results of these two studies

"Illuminate" and "Realize".

..

What's so important about the Phase III "Illuminate Study" you may ask ?

..

Well, in this study there are around 500 Hepatitis C infected individuals treating to see what the best treatment duration will be for naïve genotype 1 patients. How long is long enough ? 24 weeks or 48 weeks ?

..

What Results do you want and need from this study ?

..

Shorter treatment duration, and 100 percent SVR rates would be nice. If this drug really does cure 75 percent of naïve genotype 1 patients in only 24wks the HCV community will rejoice.

..

What does Vertex need ?

...

A shorter treatment duration so Vertex can go up against Merck's boceprevir. Will Telaprevir end up being better than boceprevir? Who knows, still waiting for boceprevirs phase III study results to be announced later in the year.

..

I'm here to say, I don't care which drug turns out to be the forerunner.

..

Go VERTEX !

Go MERCK!

..

Take it all the way, this disease needs a therapy home run!

...

Back to the studies at hand, the other phase III study is the "Realize study". This study is for patients who previously failed or relapsed with current therapy. The outcome of this study is so important; for everyone who is waiting to treat a second, or even a third time. It looks pretty good for them and for Vertex. If these results turn out like vertex anticipates we all win. Sorry boceprevir.

k.

The rumor mill is full of news folks; Vertex/ &

will be seeking regulatory approval for telaprevir in the second half of 2010, is this because of the positive results from the Advance study ? Sure is.

,,

Speaking of the rumor/gossip mill did you watch the New York Housewives reunion show, never mind.

,

Still speaking of the mill, I guess I should mention that in the future "Vertexs" next drug combination could be Teleprevir and VX-222.

Its in phase II and will eliminate treatment with SOC, or Pegylated Interferon and ribavirin. If this happens then anyone treating HCV will no longer be giving themselves a shot, nope, pills only folks. The pills will be directly killing the virus.

Wake me up and call my Momma, can this really happen, I hope so.

,/.

On with more good news !.

..,

Telaprevir : Lets Breakdown That "Advance Study"

...

In this study there were 1,095 patients who never treated before, or treatment virgins. Treatment duration was 24-weeks with "telaprevir-based regimens". Except in the control study-these people treated with "SOC" or without Telaprevir" for 48wks.

..

What Is SOC ?

,.

SOC=Standard Of Care

Treatment with (pegylated interferon/ribavirin)

...

,SOC Treatment Protocol as follows:

,

Remember this is SOC/Pegylated Interferon/Riba. Which is

FDA approved and currently the drug of choice for treating HCV.

,

If you have genotype 1 or 4 you are generally given 12 monthsof treatment and have about a 50% chance of a cure.If you have genotypes 2 or 3 you are generally givensix months of treatment and have a 70–80% chance of a cure.

...,,.

What Is The

"Telaprevir-based combination regimen ?"

..

Telaprevir with/Pegylated-interferon and Ribavirin

Buzz Word : Triple Therapy

..//

On with the study...

..

The Three Treatment Groups or Arms

In The Advance Study

../

.../

Group 1.....Treated for 12-weeks with telaprevir-based combination regimen (triple therapy), followed by 12 wks of treatment with pegylated-interferon and ribavirin alone.

"Group 1" is also referred to in some articles as the "12+12" arm

Buzz Word : 12+12

..k.

Group 2..... Treated for 8 weeks with telaprevir plus SOC= standard of care, followed by 16 weeks of standard of care alone

..

Last but not least the " Heroes "

..

Group 3.....,,, This group of patients were the control for the study, receiving SOC=standard of care only, "No Telaprevir" for a full 48 weeks.

...

THE RESULTS

..

Group 1 ,,,,,,,75% of patients achieved a viral cure=defined as undetectable levels of virus measured six months after treatment stopped.

,

Relapsed at a rate of 8.6%

,,

Group 2,,,, 69% achieved a viral cure (relapse rate?)

,,

Group 3,,,,, 44% of patients treated with just standard of care achieved a viral cure

,

Relapsed at a rate 28%

,,.

..

Due to adverse events (side effects) the treatment discontinued percentages were 6.9% and 7.7% in Group 1 and 2 . This percentage by the way is lower than previous trials.

..

1.4% of the discontinuation rate was due to that rash .

..

..

What rash ?

..

We can hype this up, but instead lets just give you the facts. Previously in Telaprevir studies there has been a 9 percent drop out rate because of the skin rash. The take home message here is that the rash in this study was low and is manageable.

d..

For the record and important

..

More on the rash and results from

...

Adam Feuersteinhttp://www.thestreet.com/

../

..

"Will the FDA (and later, hepatitis C doctors and patients) be worried about that one telaprevir-treated patient in the phase III study diagnosed with s- syndrome?

,.s- Syndrome (SJS) is a rare, life-threatening rash. Vertex disclosed that a single patients treated in the eight-week telaprevir arm was diagnosed with SJS, albeit 11 weeks after telaprevir dosing had ended. For that reason, Vertex says study safety monitors ruled out telaprevir as the cause for the case of SJS. The patient was hospitalized and made a full recovery.

k.Telaprevir-treated patients discontinued from the study due to rash at a surprisingly low (and positive) rate of just 1.4%. Still, telaprevir can cause rash, so the disclosure of even a single case of SJS puts the drug's safety profile under further scrutiny"

..

As for the results ?

...

How many telaprevir patients are actually cured after just 24 weeks of treatment?

...

Vertex is being a bit cagey, saying only that 70% of the 75% of viral cures were in patients treated for 24 weeks.

...Bank of America/Merrill Lynch analyst McMinn estimates that this translates in 55% of telaprevir patients overall achieving viral cure with a 24-week treatment regimen. That's lower than what was observed in the previous phase II studies of telaprevir. Vertex says more advanced, difficult-to-treat hepatitis C patients enrolled in the phase III study compared to previous studies explains the difference.

k.This metric is important because cutting treatment time for hepatitis C in half (from one year to six months) is one of the key selling points that Vertex will use to market telaprevir -- and potentially differentiate the drug from Merck's boceprevir which will likely require longer treatment.

,.That message is diluted a bit, however, if the study results show that only about half of hepatitis C patients treated with telaprevir will be cured at 24 weeks (the rest needing 48 weeks of treatment.) Half is still better than none, which is what happens today, but half isn't as good as it could be, either.

..

Continue reading...........

..

Is your Physician up to date ?

..

One Year After the Launch of Telaprevir and Boceprevir, Surveyed Physicians Expect to Prescribe Triple Therapy Regimens to 90 Percent of Their Hepatitis C Virus PatientsTwenty-Five Percent of Surveyed MCOs Expect to Add Both Telaprevir and Boceprevir to Their Formularies, According to a New Report from Decision Resources

..

Continue reading..............

..

You know that's a pretty good question, isn't it ? Is your physician on board here with the new oral inhibitors. Wait, lets start over, is your physician on board with Telaprevir or Boceprevir?

..

Because folks if you're newly diagnosed you should be treating with these new drugs. If you can't get into a trial (not any to speak of now) or missed your chance then wait for the FDA approval because the wait wont be long. (Depending on what part of the world you live in).

..

If we look back at when Pegasys and Pegintron were FDA approved they continued the clinical trials, remember? This is a great way to treat if you're not insured.

..

Treatment is a personal thing, not everyone is ready or willing to commit to therapy. Some people have such a small amount of liver damage they feel treatment isn't necessary. Like I said, its a personal thing.

..

If you aren't ready then skip it, because you'll be looking for reasons to stop. If you are ready and willing to commit to the HCV treatment regimen then do your homework.

..

If the treatment duration turns out to 24wks, or 12wks for certain genotypes , its going to be pretty tempting, isn't it ? Especially with the SVR stats, and if you don't respond pretty quickly they discontinue treatment.

..

It wasn't that easy back in the day when the dinosaurs treated. Nope, I was in a trial for genotype 2, high viral load. Treated for 48 weeks, first couple months dosed daily, stop me now before I have a flashback. But now treatment may be a whole different ballgame, right ?

..

I will close this entry with something my gastroenterologist told me when I asked if I should go on treatment. (Year 1999/ Still SVR 2010).

..

He said " Why would you want to live with HCV ?

..

I treated .

..

bt

b

Jun 11, 2010Vertex Pharmaceuticals Announces Webcasts of its Presentations at Three Investor ConferencesJun 1, 2010Vertex Pharmaceuticals Announces Webcasts of its Presentations at Two Investor ConferencesMay 25, 201075% of Treatment-Naïve Patients

with Chronic Hepatitis C Achieve SVR (Viral Cure) with Telaprevir-Based Treatment in Phase 3 TrialMay 13, 2010Shareholders of Vertex Pharmaceuticals Approve Proxy Proposals at Annual MeetingApr 27, 2010Vertex Pharmaceuticals Announces Webcasts of its Presentations at Two Investor Conferences

References:

http://www.hivandhepatitis.com/hep_c/news/2010/0608_2010_a.htmlhttp://www.vrtx.com/current-projects/drug-candidates/telaprevir-VX-950.html

http://www.bioworld.com/servlet/com.accumedia.web

http://Hepatitis Cnewdrugs.blogspot.com/2010/06/telaprevir-easy-to-understand-review.html